Clin Res Cardiol (2022).

Outcomes of transcatheter aortic valve implantations requiring a surgical bailout in Germany
V. Oettinger1, M. Zehender1, C. Bode1, C. von zur Mühlen1, K. Kaier2, D. Dürschmied3, P. Stachon3, für die Studiengruppe: CeBAC
1Innere Medizin III, Kardiologie und Angiologie, Universitätsklinikum Freiburg, Freiburg im Breisgau; 2Institut für Medizinische Biometrie und Statistik, Universitätsklinikum Freiburg, Freiburg im Breisgau; 3I. Medizinische Klinik, Universitätsklinikum Mannheim, Mannheim;

Background: Major complications during transcatheter aortic valve implantation (TAVI) can force a surgical bailout, but little is known about the resulting outcomes in Germany.
Methods: Using German national records, all TAVI between 2007 and 2019 were identified, with focus on 2018 and 2019. Furthermore, those procedures requiring surgical bailout were extracted.
Results: A total of 136,671 patients received TAVI. Overall rate of surgical bailout was 2.58% and overall in-hospital mortality 4.11%. In-hospital mortality after surgical bailout was 16.04%. While the annual number of procedures in all TAVI rose steeply (202 to 22,419), the rate of surgical bailout dropped from 27.23 to 0.69% and that of overall mortality from 11.39 to 2.50%. However, mortality in case of surgical bailout remained high with 26.45% in 2019. After risk adjustment, in 2018 and 2019, standardized rates of overall in-hospital mortality and surgical bailout for both balloon-expandable and self-expanding transfemoral TAVI were significantly lower than for transapical TAVI (transapical vs transfemoral balloon-expandable vs self-expanding TAVI: in-hospital mortality: 5.38% [95% CI 4.43;6.33] vs 2.43% [2.12;2.75] vs 2.39% [2.11;2.67]; surgical bailout: 2.43% [1.67;3.19] vs 0.83% [0.61;1.05] vs 0.45% [0.33;0.58]). Main risk factors for surgical bailout were coronary artery disease (risk adjusted OR=1.44 [1.12;1.85], p=0.005) and higher grade heart failure NYHA III/IV (OR=1.42 [1.09;1.85], p=0.010).
Conclusion: Rates of TAVI requiring a surgical bailout as well as overall in-hospital mortality drop substantially over the years. However, in case of surgical bailout, the outcomes remain poor with consistently high in-hospital mortality.

Figure: Standardized rates of in-hospital mortality and surgical bailout for TAVI in 2018 and 2019